At this time, Zenpep (pancrelipase) capsules are available in brand-name form only. After the first patent for the drug expires in February 2028, however, companies may be allowed to manufacture a generic Zenpep product. Although pancrelipase is considered the "generic name" for Zenpep, it is simply the active ingredient in the drug and not a generic version of it.
Can I Buy Generic Zenpep?
Zenpep® (pancrelipase) is a prescription medication approved to treat pancreatic digestive enzyme deficiencies, such as the type of deficiency that occurs with cystic fibrosis. It is taken by mouth with each meal and snack.
Zenpep is made by Eurand Pharmaceuticals, Inc. It is protected from generic competition in the United States by an unexpired patent.
When Will a Generic Version Be Available?
The first patent for Zenpep is set to expire in February 2028. This is the earliest predictable date that a generic version could become available.
However, other circumstances could come up to extend or shorten this exclusivity period. This could include such things as lawsuits or other patents for new Zenpep uses. Once the patent expires, there may be several companies that manufacture a generic Zenpep drug.
Is Pancrelipase a Generic Zenpep?
No -- pancrelipase is the active ingredient in Zenpep, not a generic version of it. What can be confusing is that the active ingredient of a drug is often referred to as the "generic name."
The generic name is different from a generic version of a medicine. In order for there to be a generic version, the original medicine must have gone off-patent and another company besides the original manufacturer must make the product.
There are a few other brand-name pancrelipase drugs, but they are not directly interchangeable. Different pancrelipase products have different mixtures of the various enzymes.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
Food and Drug Administration, Center for Drug Evaluation and Research. Electronic orange book: approved drug products with therapeutic equivalence evaluations. FDA Web site. Available at: http://www.fda.gov/cder/ob/. Accessed January 3, 2013.
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